Addressing Treatment Nonresponders

Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children

The goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.

Study Overview

• Status: Not yet recruiting
• Conditions: Language Development Disorders
• Intervention / Treatment: Behavioral: VAULT Phase 6

Detailed Description

Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mary Alt, PhD; Phone Number: 520-626-6180; Email: malt@arizona.edu
• Study Contact Backup: Name: Nora Evans-Reitz, m; Phone Number: 520-626-6885; Email: nevansreitz@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Native English Speaking
• Pass pure tone hearing screening or medical report of normal hearing
• 2-3 years at start of study
• MacArthur-Bates Communicative Development Inventories (MCDI) expressive scale <10th percentile

Exclusion Criteria:

• Parental report of other diagnoses
• Enrolled in concurrent treatment elsewhere
• Nonverbal IQ <75 as measured by the Bayley Scales
• Parents unable to consistently bring child to treatment sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alternative Treatment Including Augmentative and Alternative Communication; Once children are shown to not respond to the usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment, they will be placed in this arm, which will train them to use an Augmentative and Alternative Communication device as an additional means to use to 'say' a word.	Behavioral: VAULT Phase 6; VAULT is an input-based word learning intervention based on principles of statistical learning.
Active Comparator: Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment; Children who do appear to respond to treatment will continue with the full course of usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) intervention.	Behavioral: VAULT Phase 6; VAULT is an input-based word learning intervention based on principles of statistical learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Effect Size	The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).	Change from baseline through treatment, which will average an 8-week time frame.
Number/Rate of words learned	The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment and measured during, immediately following, and 4-6 weeks after the treatment.	Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Treatment Retention	We will use probe data or specific words and parental report to determine how many of the words the child retained from treatment.	Change from end of treatment to follow up, which will average 4-6 weeks.

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Mary Alt, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Late Talkers
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Language Development Disorders
• Other Study ID Numbers: Late Talker Phase 6; 2R01DC015642-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No